510(k) Report

Devices descending from K980817

312 later devices reach Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K190814AccuFill Bone Substitute MaterialZimmer Knee Creations20190—
+7K182107CarriGen PFEtex Corporation20181—
+7K143547Vivorte Trabexus EBVivorte, Inc.201501
+7K102528N-Force Fixation SystemInnovision, Inc.20115—
+7K102812Gamma-BSM; Beta-BSM; EquivaboneEtex Corporation20100—
+8K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+8K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—
+8K151146N-Force Fixation SystemInnovision, Inc.20151—
+8K142776Flow-ScrewFlow-Fx, LLC20151—
+8K132244N-Force Fixation SystemInnovision, Inc.20143—
+9K173556Injection ScrewBiedermann Medtech, Inc.20180—